Devices and methods for managing chest drainage

ABSTRACT

Disclosed is a chest drainage system which reduces or eliminates pooling of blood/liquid and/or clogging/clotting in the drainage tube. Generally, the chest drainage system continuously monitors chest tube status and clears pooled liquid when necessary to restore negative pressure to the chest. The system may include a valve device which is located between the patient&#39;s chest tube and drainage tube and may be used with any standard chest tube. The chest drainage system also includes a controller for monitoring the pressure at or near the valve device and/or at or near the suction device, and possibly a pump for assisting in clearance of pooled liquid and/or clots. The controller may also control the valve device and/or suction device in response to pressure signals.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/892,098 filed Jun. 3, 2020, which is a continuation of U.S. patentapplication Ser. No. 15/422,323 filed Feb. 1, 2017, which is acontinuation of International Patent Application No. PCT/US2015/052960filed Sep. 29, 2015, which claims the benefit of priority to U.S.Provisional Application No. 62/056,683 filed Sep. 29, 2014 and U.S.Provisional Application No. 62/136,488 filed Mar. 21, 2015 and U.S.Provisional Application No. 62/149,559 filed Apr. 18, 2015 and U.S.Provisional Application No. 62/181,031 filed Jun. 17, 2015, each ofwhich is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to wound and surgical drainage.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if each suchindividual publication or patent application were specifically andindividually indicated to be so incorporated by reference.

BACKGROUND OF THE INVENTION

Chest tubes are required anytime air or liquid accumulates in the chestcavity, disrupting normal pulmonary or cardiac function. Suction isapplied continuously to remove any air or fluid from the chest until theinternal leaks have sealed, at which point the chest tubes can beremoved. One of the most common uses of chest tubes is to drain the areaaround the heart after cardiac surgery.

Despite their benefits, current chest tube systems suffer from two majorflaws. First, as liquid drains from the chest toward the suctioncontainer, it can pool in the drainage tubing and prevent the appliednegative pressure from being transmitted to the chest. When this occurs,the pressure in the chest can be reduced to zero or even becomepositive. Second, clogs can form that obstruct the chest tube, whichprevent the negative pressure from being transmitted to the chest andinhibit drainage. In fact, 36% of cardiac surgery patients experiencechest tube clogging. When proper drainage is inhibited due to thesefactors, patients are at increased risk for accumulation of fluid aroundthe heart, known as pericardial tamponade, which results in shock andcan be fatal. Additionally, the lungs may be compressed, which can leadto respiratory compromise and be fatal as well.

Pooling of liquid in the drainage line can theoretically be remedied bykeeping the tubing straight from the patient to the collectioncontainer. However, this is nearly impossible in practice, as some slackis required to prevent accidental dislodging of the tube from the body.To combat clogging, clinicians use two methods known as milking andstripping. Milking refers to line manipulations such as lifting,squeezing, or kneading. Stripping refers to a pulling along the lengthof the tube with the thumb and forefinger to increase the amount ofsuction at the end of the tube. However, these methods have not beenshown to be effective at improving chest tube suction or drainage. Infact, stripping has actually been discouraged because it is possible tocreate extremely high negative pressures (up to −370 cmH₂O) that maydamage the tissue.

SUMMARY OF THE INVENTION

A chest drainage system is needed which reduces or eliminates pooling ofblood/liquid and/or clogging/clotting in the drainage tube.

One embodiment of the drainage system may generally comprise a suctiondevice configured to generate a negative pressure, a first lumen bodyconfigured for insertion into a patient body, a second lumen bodyfluidly coupled to the suction device, a valve assembly fluidly coupledto the first lumen body and to the second lumen body, wherein the valveassembly includes at least a first valve having a closed configurationwhere the negative pressure generated by the suction device ismaintained within the second lumen body, and the first valve furtherhaving an open configuration where the negative pressure draws air froman environment and through the second lumen body, a pressure sensor incommunication with the first lumen body, and a controller incommunication with the pressure sensor, wherein the controller isprogrammed to sense for a decrease in the negative pressure indicativeof an obstruction within the second lumen body, wherein the controlleris further programmed to actuate the first valve into the openconfiguration upon sensing the decrease to clear the obstruction. Inanother embodiment, the valve may have certain mechanicalcharacteristics, including but not limited to crack pressure, such thatit automatically open when the negative pressure decreases a certainamount, eliminating the need for the pressure sensor and controller.

Another embodiment of the drainage system may generally comprise asuction device configured to generate a negative pressure, a first lumenbody configured for insertion into a patient body, a second lumen bodyfluidly coupled to the suction device, a valve assembly fluidly coupledto the first lumen body and to the second lumen body, wherein the valveassembly includes at least a first valve having a closed configurationwhere the negative pressure generated by the suction device ismaintained within the second lumen body, and the first valve furtherhaving an open configuration where the negative pressure draws air froman environment and through the first lumen body, a pressure sensor incommunication with the first lumen body, and a controller incommunication with the pressure sensor, wherein the controller isprogrammed to sense for a decrease in the negative pressure indicativeof an obstruction within the first lumen body, wherein the controller isfurther programmed to actuate the first valve into the openconfiguration upon sensing the decrease to clear the obstruction. Inanother embodiment, the valve may have certain mechanicalcharacteristics, including but not limited to crack pressure, such thatit automatically open when a certain pressure differential existsbetween the first and second lumen bodies, eliminating the need for thepressure sensor and controller.

In one exemplary method of use, the method for draining a body lumen maygenerally comprise applying a negative pressure to a first lumen bodyinserted into a patient body, drawing a fluid from the patient body viathe first lumen body and through a second lumen body in fluidcommunication with the first lumen body, monitoring via a pressuresensor for a decrease in the negative pressure as indicative of anobstruction within the second body lumen, actuating a valve assemblycoupled to the first lumen body and to the second lumen body upondetecting the decrease such that at least a first valve in the valveassembly actuates from a closed configuration, where the negativepressure is maintained within the second lumen body, and into an openconfiguration, where the negative pressure draws air from an environmentand through the second lumen body, and clearing an obstruction from thesecond lumen body via the air introduced into the second lumen body. Inanother exemplary method of use, the valve may automatically open whenthe negative pressure decreases by a certain amount, eliminating theneed to monitor pressure and actuate the valve.

In another exemplary method of use, the method for draining a body lumenmay generally comprise applying a negative pressure to a first lumenbody inserted into a patient body, drawing a fluid from the patient bodyvia the first lumen body and through a second lumen body in fluidcommunication with the first lumen body, monitoring via a pressuresensor for a decrease in the negative pressure as indicative of anobstruction within the first body lumen, actuating a valve assemblycoupled to the first lumen body and to the second lumen body upondetecting the decrease such that at least a first valve in the valveassembly actuates from a closed configuration, where the negativepressure is maintained within the second lumen body, and into an openconfiguration, where the negative pressure draws air from an environmentand through the first lumen body, and clearing an obstruction from thefirst lumen body via the air introduced into the first lumen body. Inanother exemplary method of use, the valve may automatically open when apressure differential exists between the first and second lumen bodieseliminating the need to monitor pressure and actuate the valve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of the chest drainage system.

FIG. 2A shows an embodiment of the valve device.

FIG. 2B shows an embodiment of the valve device in use with anembodiment of a chest tube.

FIG. 3 shows another embodiment of the chest drainage system

FIG. 4 shows the chest drainage system's ability to detect and clearpooled liquid in the drainage tube.

FIG. 5 shows the chest drainage system's ability to detect clogs in thechest tube.

FIG. 6 shows an embodiment of a suction device.

FIGS. 7A-7E show an embodiment of the chest drainage system relating toclearing of a chest tube.

FIGS. 8A-8D show an embodiment of the chest drainage system relating toclearing of a chest tube.

FIGS. 9A-9D show an embodiment of the chest drainage system relating toclearing of a chest tube.

FIG. 10 shows an embodiment of the chest drainage system relating toclearing of a chest tube.

FIG. 11 shows an embodiment of the chest drainage system relating toclearing of a chest tube.

FIGS. 12-14 show other embodiments of the chest drainage system.

FIG. 15 shows a block diagram of a data processing system, which may beused with any embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Disclosed is a chest drainage system which reduces or eliminates poolingof blood/liquid and/or clogging/clotting in the drainage tube.

The chest drainage system continuously monitors chest tube status andclears pooled liquid when necessary to restore negative pressure to thechest. The system may include a valve device which is located betweenthe patient's chest tube and drainage tube and may be used with anystandard chest tube. The chest drainage system also includes acontroller for monitoring the pressure at or near the valve deviceand/or at or near the suction device, and possibly a pump for assistingin clearance of pooled liquid and/or clots. The controller may alsocontrol the valve device and/or suction device in response to pressuresignals. The chest drainage system performs four primary functions:

1. The chest drainage system detects pooled liquid in the drainage tubeby monitoring the pressure near the patient-external end of the chesttube. Pooled liquid is indicated by a decrease in vacuum (increasingpressure). The chest drainage system measures pressure with a sensor onor near the valve device. The valve device includes a vent or valvewhich prevents the transmission of bacteria and viruses.

2. When pooled liquid is detected, the chest drainage system clears thedrainage tube by opening a valve in the valve device to allow sterileair to sweep away the liquid into the drainage container. Optionally thepump may also be activated to apply positive pressure between the chesttube and drainage system and/or negative pressure at the collectioncontainer. Proper negative pressure at the chest is then restored, whichprevents clogs from forming in the chest tube.

3. In the event that clots or clogs do form, the chest drainage systemdetects clogs in the chest tube by monitoring the pressure in thedrainage tube. The chest drainage system intermittently closes thedrainage tube via the valve device and checks for pressure fluctuationsdue to respirations, which are present in the absence of clogs.

4. In the event that clots or clogs are present, the chest drainagesystem may additionally clear the clots/clogs.

The suction device of the chest drainage system connects to thepatient's bed and houses the electronics, including possibly thecontroller. The valve device may be disposable and connects to the chesttube on one end and the drainage tube on the other.

In another embodiment, the valves are mechanical tuned to activate atcertain pressures, eliminating the need for the pressure sensor andcontroller.

FIG. 1 shows an embodiment of the chest drainage system. Patient chest102 is drained using the system. Chest tube 104 is in direct fluidcommunication with the chest cavity. Drainage tube 106 is in fluidcommunication with suction device 108. Valve device 110 which includesvent/valve 112 is between chest tube 104 and drainage tube 106. Valvedevice 110 is in fluid communication with both chest tube 104 anddrainage tube 106. Valve device 110 may be controlled by a controller ormay be controlled manually. The valve device may be used to periodicallyclose off fluid flow from the chest tube and/or open vent/valve 112 toallow air to enter the drainage tube and clear any obstructions or slowfluid flow in the drainage tube. The valve device may also be used withan additional internal lumen in the chest tube to allow air to enter theproximal end of the chest tube and clear any obstructions into thedrainage tube. The valve device may also include a pump to assist withdrainage. This clearing action may be performed on a periodic basis, aswith a timer, or may be performed in response to a signal that thedrainage tube and/or chest tube is not flowing freely.

Pressure sensor(s) 114 may reside at various locations in the system.Here, a pressure sensor is shown near chest tube 104 and also nearsuction device 108. Pressure sensors may also be located in other placesin the system, for example, near the chest. Pressure sensed at one ormore location is used to determine whether there is an impediment tofluid flow through the system. If an impediment is detected, an audiblealarm may sound, and/or the controller may automatically control thevalve device to clear the drainage tube and/or chest tube. More detailon this is provided below.

Suction device 108 creates a negative pressure, or suction, force on thedrainage tube which is in fluid communication with the valve device andchest tube. In this way, suction may be maintained on the chest cavityto promote chest fluid drainage and aid with patient breathing. Themechanism for creating the negative pressure may be a pump or any othersuitable mechanism.

The controller (not shown) may be incorporated into the suction deviceand/or the valve device and/or be separate. Any communication betweenthe controller and the suction device and/or valve device may be wiredor wireless.

FIG. 2A shows an embodiment of the valve device. Connector 202 connectsto the chest tube. Connector 204 connects to the drainage tube. Duringnormal operation, blood and other fluids flow freely through the valvedevice in the direction of the arrows. Valve 208 is normally open andvalve 210 is normally closed. If an impediment to fluid flow isdetected, valve 210 may be opened to allow atmospheric or other air toenter the system through vent 212. Vent 212 prevents contaminates in theair from entering the inner lumen of the valve device and therefore thefluids within the system remain sterile. Because negative pressure isbeing applied to connector 204 via the suction device, air will flowthrough the system and clear the drainage line. Valve 210 may then beclosed to allow for normal drainage. The opening and closing of valve210 may be performed manually, or automatically via control of thecontroller based on the measured pressures in the system, orautomatically based on mechanical characteristics of the valve,including but not limited to crack pressure. Multiple openings andclosings of valve 210 may be necessary to clear the line. Valve 208 mayor may not be closed during the clearing process, or may be closed forpart of the clearing process. When valve 208 is closed, all the negativepressure created by the suction device is applied to the drainage tubeand will be used to allow air to enter and clear the system. When valve208 is open, some of the negative pressure will be applied to the chesttube which may aid in clearing any clots/obstructions in that area.Valve 208 may only be opened if the obstruction is not cleared byopening valve 210 alone. When valve 208 is open, care must be used tomake sure the chest is not exposed to too much negative pressure whichcould cause injury. When valve 208 is closed, higher magnitude negativepressure can be used to clear any blockage if necessary. Optionally,when valve 208 is closed and valve 210 is open, the pump may applypositive pressure across vent 212 to assist with drainage.

Also shown in FIG. 2A is container 206 which houses the variouscomponents of the valve device, and pressure sensor 214, which may beincorporated into the valve device.

The valves may be any suitable type of active valve, such as a pinchvalve, solenoid valve or ball valve. The valves may alternatively bepassive valves, such as one-way valves, pinch valves, check valves, etc.For example a passive one-way valve or valves may be used which allowschest drainage when suction is applied to the tube, but passively closesoff to prevent flow into the chest when positive pressure is applied tothe tube.

FIG. 2B shows an embodiment of the valve device in use with anembodiment of a chest tube. This embodiment is used to clear a blockagein the chest tube. Valve device 228 includes valve 216 with filter andoptional pressure sensor 226. Chest tube 230 is connected to valvedevice 228 so that the two lumens of the chest tube are in fluidcommunication with the lumens of the valve device. Lumen 220 carries airtoward the patient. Lumen 222 carries blood/fluids away from thepatient. The non-patient side of valve device 228 is connected to adrainage tube and a source of negative pressure. Opening 224 allowsfluid communication between lumen 220 and lumen 222. A valve may or maynot exist in opening 224. Lumen 222 is open on the patient end so thatblood/fluids can drain from the patient. Lumen 220 is closed at patientend shown here as air lumen end 224. Optional valve 218 may becontrolled by the controller to close off lumen 222 to the chest/bodycavity so that air is prevented from entering the patient cavity.

When a blockage is present in the chest tube, either detected viapressure sensor 226 or otherwise, valve 216 is opened to allow air orgas, from the atmosphere or otherwise, to enter lumen 220. Negativepressure applied to lumen 220 may also be increased by the controller.The opening of valve 216 allows air/gas to enter the system and urgesthe contents of lumen 222 to travel away from the patient and throughthe chest tube and into the drainage tube (not shown here). After thechest tube blockage is cleared, either as sensed by pressure sensor 226or automatically or manually, valve 216 is again closed and valve 218,if it is present, is again opened. If the negative pressure wasincreased, it is again decreased and fluid can again flow freely throughlumen 222 and into the drainage tube. Valve 216 and valve 218 may becontrolled by the controller or function automatically or manually.Wired communication between the controller and valve 218 may existwithin a lumen of the chest tube or embedded within a wall of the chesttube. Communication between any of the valves and the controller mayalso be wireless. Valve 216 may open automatically based on pressuredifferentials across the valve. Valve 218, which may or may not bepresent, may also close automatically based on pressure differentialsacross the valve.

FIG. 3 shows another embodiment of the chest drainage system. In thisembodiment valve device 302 is located near, or incorporated into,suction device 304. The valve device is connected to a separate tube,valve tube 306. Pressure sensor(s) (not shown) may be located anywherein the system, including near the chest and/or chest tube. If drainagetube 308 becomes blocked, as sensed by the pressure sensor(s), valve 312is opened to allow clearing of the line. Valve 310 may also be closed,analogously to valve 208 in FIG. 2A. If a pump is used, it can assistwith drainage by pumping through valve tube 306 and drainage tube 308back into the collection container. Alternatively, the suction withinthe container may be controlled by the device, increasing in vacuummagnitude when valve 312 is open and valve 310 is closed in order toclear the drainage line. Valves 310, 312, valve device 302 and suctiondevice 304 are controlled by a controller which may be incorporated intothe suction device and or valve device, or may be separate.Communications with the controller may be wired or wireless.

FIG. 4 shows the chest drainage system's ability to detect and clearpooled liquid in the drainage tube. In section ‘A’, −10 cmH2O ofpressure is properly transmitted to the chest. In section ‘B’, liquidbegins to pool in the bottom of the tube, resulting in a decreasednegative pressure. If unresolved clinically, drainage would be impeded.However, in section ‘C’ a valve in the valve device is opened and theliquid is flushed into the drainage container, resulting is restorationof proper suction in Section ‘D’. In this example, the pressure sensoris at or near the chest or chest tube. However pressure may be measuredin other and/or additional locations in the system. For example,pressure may be measured at or near the chest or chest tube and also ator near the suction device, and the differential pressure measurementmay be used to detect flow impediments or pooling or clotting ofblood/fluid.

In this way, the controller can identify impediments to fluid drainagevia the absolute pressure, change in pressure, pressure differentialbetween or among 2 or more locations etc. When an impediment to fluiddrainage is identified, an alarm may sound and/or the controller mayinitiate clearing procedures, including opening and/or closing valve(s)in the valve device, as described elsewhere herein. The negativepressure may be increased, or changed in other ways, such as pulsed,reversed etc.

For example, if a pressure sensor near the chest is reading around −10cmH20 to around −20 cmH20 and the reading changes to zero to −5 cmH20,the controller may open the valve to air in the valve device. Thecontroller may also close the valve to the chest tube in the valvedevice. The controller may leave the valves in this position for a setperiod of time, say 5-10 seconds or 10-30 seconds and then may returnthe valves to their regular positions. The controller will then checkthe pressure readings and if they have returned to normal, do nothingmore. If they have not returned to normal, indicating a blockage orslowing condition is still present, the controller may repeat theclearing procedure. This may be done repeatedly until the tubing iscleared. Alternatively or additionally, the procedure may change ifrepeat clearings are necessary. For example, the magnitude of negativepressure used by the suction device to clear the tubing may beincreased, and/or the negative pressure may be pulsed. The clearingprocedure may be performed in response to the pressure readings or itmay be done automatically on a periodic basis.

FIG. 5 shows the chest drainage system's ability to detect clogs in thechest tube. In sections ‘A’ and ‘C’ normal suction is applied. Insection ‘B’, the chest drainage system has entered clog detection modeand is watching for pressure fluctuations in the drainage system due torespirations. When no clog is present, the fluctuations are clearlyseen, but when a clog is present, fluctuations are no longer observed.When a clog is detected, the chest drainage system sounds an alarm toalert the clinician, allowing for timely intervention. Alternatively,the chest drainage system automatically begins clog/clot eliminationprocedures. These procedures may include draining the drainage tube, asdiscussed elsewhere herein. In addition, these procedures may includeapplying energy to the chest tube and or the fluid column, includingultrasonic energy, vibrational energy, sound energy, mechanical energy,squeezing energy etc. The energy may be provided by the pump motor ormay be provided by another source or sources.

The chest drainage system is of particular importance with pediatricpatients. The amount of suction applied to the chest in adults is around−20 cmH20, but with children it is limited to around −10 cmH2O to avoiddamaging their more fragile tissues. With less suction, it is moredifficult to clear pooled liquid or clots. Therefore the chest drainagesystem may be even more beneficial with pediatric patients.

FIG. 6 shows an embodiment of a suction device. Pump 602 pumps in thedirection of the arrow to create negative pressure in the system.Drainage tube 604 is connected to fluid collection reservoir/container606.

The chest drainage system may be used in conjunction with a hospital'sown drainage and/or chest tubes. More than one chest tube and/ordrainage tube may be employed by the system. In the case of multiplechest tubes, the tubes may utilize shared or separate drainage tubes. Ifseparate, the chest drainage system may monitor pressure and activateclearing procedures and/or sound alarms on the drainage tubesindividually. Alternatively, more than one chest tube may be connectedto one valve device. One suction device may be used with multiple valvedevices.

The chest drainage system may also include a chest tube which isdesigned to aid in clearing clots in the chest tube. For example, thechest tube may include an inflatable balloon or bladder which pushesfluid and clots toward the drainage end of the tube. The chest tube mayinclude a mechanical device which automatically or manually pushes fluidand clots toward the drainage end of the tube. The chest tube mayinclude more than one tube, either coaxial or other wise which can bemoved either longitudinally or radially with respect to each other orboth. For example, the chest tube may include a tube within its drainagelumen which can be moved with respect to the drainage lumen to dislodgeclots and return flow within the lumen to normal. This movement may bemanual or automatic, and may be of small magnitude, such as avibrational movement, or may be of a larger magnitude, such as 1-10 mmor 1-3 cm. The energy to move the tubes may be provided by the pumpmotor of the pump device.

In some embodiments, the pump device may be incorporated into the valvedevice. This combination device may be at the drainage end of thedrainage tube, or may be between the chest tube and the drainage tube.It may alternatively be incorporated into the chest tube.

In some embodiments, the chest drainage system may include a pH sensor.Post-surgery infection and empyema are of particular concern toclinicians. The pH of fluid drained from the body can be useful indiagnosing these, and other, conditions. To aid in the diagnosis, thechest drainage system may include a pH monitor in the tubing, the pump,the valve device, or anywhere in the system. The results may bedisplayed on the display device.

FIGS. 7A-E show an embodiment of the chest drainage system whichincludes a balloon for dislodging clots and/or clogs in the chest tube.FIG. 7A shows the end of a chest tube which is placed into the chest ofa patient. Some, or all, of this portion of a chest tube may be thechest of a patient. Chest tube 702 includes opening 706 and drainageholes 708. In this figure the left side of the figure/device will bereferred to as the “chest end”. The opposite end of the device/figurewill be referred to as the “outside end”. Blood clots or other clogs 710are shown here also. When clots/clogs are present in a chest tube, thechest tube clearing component of the chest drainage system 712 may beintroduced into the chest tube as shown in FIG. 7B. Chest tube clearer712 may be introduced via a Y-adapter at the chest tube/drainage tubeinterface. Alternatively, chest tube clearer may be incorporated intochest tube 702. The chest tube clearer may or may not be moveable withinthe chest tube.

Chest tube clearer 712 includes inner shaft or wire 716, and balloon 714connected to the inner shaft, as shown in FIG. 7C. Balloon 714 isinflated via an inflation lumen that is fluidly connected to the insideof the balloon, runs through the shaft, and terminates outside of thepatient. The balloon can be inflated and deflated via the inflationlumen from outside the patient. Inflation/deflation can be performedwith a syringe, inflation device, manually or automatically. Ballooninflation pressure is about 10 psi to about 400 psi. Alternativelyballoon inflation pressure is about 10 psi to about 50 psi.Alternatively balloon inflation pressure is about 50 psi to about 100psi. Alternatively balloon inflation pressure is about 100 psi to about200 psi. Alternatively balloon inflation pressure is about 200 psi toabout 400 psi.

FIG. 7C shows balloon 714 at the initial stage of inflation. The balloonof the chest tube clearer is designed to inflate first at or near thechest end of the chest tube. As balloon 714 is inflated further, theballoon inflates further within the chest tube, as is shown in FIG. 7D.The movement of the contents of the chest tube caused by the inflationof the balloon help move clots and/or clogs within the chest tube out ofthe patient and out of the chest tube. FIG. 7E shows a fully inflatedballoon. The balloon is then deflated which allows the blood to againdrain freely from the chest through the chest tube to the drainage tube.

The balloon can be any effective length. The balloon can be around aslong as the chest tube, for example up to around 50 cm long, or may bemuch shorter, for example around 10 cm long. The balloon may be inflatedwith air, gas, liquid, or any appropriate fluid.

The balloon may be manufactured out of either compliant or non-compliantmaterial, or a combination of both. In a preferred embodiment, the OD ofthe inflated balloon is approximately the same size as the ID of thechest tube, however, the OD of the inflated balloon may be smaller orlarger than the ID of the chest tube. The average OD of the deflatedballoon is designed to fit easily through the chest tube. Preferably,the average OD of the deflated balloon is significantly smaller than theID of the chest tube, so that blood and fluids can easily drain betweenthe two when the chest tube clearer is in place within the chest tube.Vacuum may be applied to the balloon to reduce the deflated OD of theballoon. For example, the OD of the inflated balloon and the ID of thechest tube may be from around 8 mm to around 9 mm, and the average OD ofthe deflated balloon may be around 1 mm to around 2 mm. In anotherexample, the OD of the inflated balloon and the ID of the chest tube maybe around 4.5 mm to around 5.5 mm, and the average OD of the deflatedballoon may be around 1 mm to around 2 mm.

The balloon may be designed to inflate closer to the chest end of thechest tube first by placement of the inflation hole, or the hole whichfluidly communicates the interior of the balloon with the inflationlumen. The inflation hole may be close to the chest end of the chesttube clearer. Alternatively there may be multiple inflation holes, thelargest of which is nearer the chest end of the chest tube clearer. Theballoon may also be folded into a shape that encourages the chest end toinflate first. For example, the chest end of the balloon may be wrappedless tightly than the rest of the balloon. Specific folding geometriesmay be utilized. For example, pleated and/or folded and/or spiral foldedballoons may be used. Some of the specific folding geometries mayincrease the unfolding pressure as well as exert a spiral motion, ortorsional, force upon any clots/clogs in the chest tube, which may helpclear the chest tube. The chest end of the balloon may also be larger,or more compliant than the rest of the balloon to encourage inflationthere first. The balloon may require a relatively high pressure to open,or overcome the folding/compression, for example, about 5 psi to about30 psi. This along with an inflation hole nearer the chest end of thechest tube clearer, will force the chest end of the balloon to inflatefirst. Note that the pressure to open the balloon and the pressure toinflate the balloon may be different pressures. Opening the balloonrequires overcoming the folding, compression or other initial inflationpressure of the balloon. The inflation pressure of the balloon is thepressure used to keep the entire balloon open, and possibly exert forceonto surrounding materials, such as clots, etc.

FIGS. 8A-8D show another embodiment of the chest tube clearer. In thisembodiment, there are multiple balloons rather than one balloon. FIG. 8Ashows the chest tube clearing device placed within the chest tube. Theballoons of the chest tube clearing device are not inflated and there isspace between the outside of the chest tube clearer and the inside ofthe chest tube for blood/fluids to flow.

FIG. 8B shows first balloon 802 inflated within the chest tube.

FIG. 8C shows second balloon 804 inflated. This figure shows firstballoon 802 still inflated, but it is also possible that first balloon802 deflates after second balloon 804 is inflated.

FIG. 8D shows multiple balloons inflated. The balloons are inflated inorder, or sequentially, from the chest end of the chest tube toward theoutside end of the chest tube. The balloons may inflate within theentire length of the chest tube, or just a portion of the length of thechest tube. In this way, clots and/or clogs are pushed out of the chesttube and out of the patient into the drainage tube. The balloons mayalso be inflated in any other preferred order.

The multiple balloons in this embodiment may be inflated via multipleinflation lumens, or one inflation lumen. There may be one, two, threeor more balloons. Balloon length may be as short as around 1 cm or aslong as around 20 cm.

FIGS. 9A-9D show another embodiment of the chest tube clearer. In thisembodiment, the balloon, or balloons, are repeatedly inflated anddeflated. This action may apply to any of the embodiments herein. Inthis manner, the chest tube clearer can break up the clots/clogs wheninflated, and allow blood and fluids to flow through the chest tube whendeflated. The balloon(s) may or may not inflate preferentially from thechest end in toward the outside end. The balloon(s) may alternativelyinflate and deflate all at once, or relatively all at once, along thelength of the chest tube. In this way, the balloon(s) may pulse, or evenvibrate or flutter within the chest tube to clear the chest tube ofclots/clogs. The balloon(s) may also be inflated to a relatively lowpressure, so that it/they are slightly lax, and flutter naturally. Anyof these or other inflation/deflation programs may be controlled by acontroller. For example, the pulse rate, balloon inflation time, balloondeflation time, etc. may be controlled by a controller.

FIG. 10 shows an embodiment of the chest tube clearer with multipleballoons. In this embodiment, shaft 1002 includes balloon inflationopening 1004 which is relatively near the chest end of the chest tubeclearing device. The multiple balloons are connected by lumens orchannels 1006 which allow air and/or fluid to flow from the firstballoon to the second balloon etc. In this embodiment, the firstballoon, the balloon closest to the chest end of the chest tube,inflates first. When the pressure within the first balloon reaches acertain threshold, the inflation fluid “leaks” into the second balloonvia channel 1006 to inflate the second balloon after the first balloon.When the pressure within the second balloon reaches a certain threshold,the inflation fluid “leaks” into the third balloon, and so on. In thisway, the balloons in this embodiment inflate closer to the chest endfirst, and closer to the outside end last.

FIG. 11 is another embodiment of the chest tube clearer with multipleballoons. In this embodiment, shaft 1002 terminates inside the firstballoon, with open end 1102. Shaft 1002 may be mounted on wire 1104 forstability, so that the first balloon may be bonded to the end of wire1104. This allows for a large balloon inflation opening, 1102, withoutsacrificing rigidity of the shaft.

Note that any of the embodiments of the chest tube clearer canintermittently close off the chest tube so that any negative pressureapplied to the drainage tube will not be applied directly to the chestcavity. This allows higher negative pressures to be used to drain thedrainage tube. In other words, the balloon(s) in the chest tube clearercan essentially serve the function of valve 208 in FIG. 2A.

Other embodiments of the chest drainage system are envisioned. Forexample:

the chest tube itself may be tapered so that the diameter of the insideof the tube gets smaller on one end or the other.

A wire, filament, or other disrupter of any sort may be used to dislodgeclots/clogs in the chest tube. The movement, vibration, rotating/screw,sliding etc. of this disrupter may be automated, either on a timeschedule, or in response to the system sensing a clog in the chest tube.

Other balloon configurations are envisioned. Some of these are shown inFIG. 12.

The chest tube itself could be configured to vibrate, or move in somemanner to dislodge clots.

The negative pressure (suction) exerted on the chest tube by the chestdrainage system could be pulsated or applied in a patterned or randomway.

A catheter, tube, and/or lumen may be used to spray fluid and/or drug,such as saline, heparin etc. into the chest tube.

The inside of the chest tube may be coated with a slippery and/orhydrophobic substance and/or drug, such as Teflon, silicone, heparin,etc. The inside of the chest tube may be textured in a way to increaseflow, such as with dimples similar to those on the outside of a golfball.

A bellow or bellows may be placed or incorporated into the inside of thechest tube.

The diameter of the chest tube may change over time. For example, thechest tube diameter may be designed to increase or decrease occasionallyto break up clots/clogs. This change in diameter may occur on a regularschedule or in response to detecting a clot situation. The diameterchange may fluctuate constantly.

The temperature of the chest tube may be increased or reduced fromambient and/or patient temperature.

A tube may be inserted or incorporated into the chest tube which has anouter diameter close to the inner diameter of the chest tube. This innertube may have holes in it which match the location of the holes of thechest tube. The inner tube may be moved relative to the chest tube tobreak up clots, particularly at the chest tube holes.

The chest tube may incorporate inner valves.

Air bubbles may be introduced into the chest tube to help clear thechest tube.

A wire, filament thread, etc. may cycle through the chest tube as isshown in FIG. 13.

A pre-shaped corkscrew wire, such as made from Nitinol, stainless steel,metal, polymer or other suitable material, may be deployed to corkscrewalong the inner wall of the chest tube, then pulled axially toscrape/remove any clots adhered to the wall of the chest tube. Thepre-shaped wire cross section may be designed such that ashoveling/scooping/peeling action occurs as the wire is pulled axiallyalong the length of the chest tube. The pre-shaped wire may also remainstationary and rotated to remove the clot from the chest tube similar toan auger. The pre-shaped wire may form a variable diameter along thelength of the tube, such that sections of the pre-shaped wire touch theinner wall of the tube and other sections do not. The wire could berotated and axially moved along the wall of the tube to urge the clot tomove through the tube to the collection chamber. The cross section ofthe “wire” of the corkscrew wire may be round, flat, or other suitableshape.

A ball or cage may be incorporated into the chest tube at the chest endof the chest tube to help blood/fluids enter the tube.

The chest tube may have multiple arms/lumens at the chest end to helpblood/fluids enter the tube.

The chest tube may incorporate a steering mechanism, for example acurved mandrel, to help steer it to better collect blood/fluids.

The chest tube may incorporate a weight at the chest end to help itdrain pooled blood/fluids.

The chest tube may include an anchor at the chest end to anchor it tothe inside of the chest wall. For example, see FIG. 14.

Detecting Infection

In some embodiment of the chest drainage system, the collectioncontainer, or other component in the system, may include the ability todetect bacteria, blood and/other substances in the drainage fluid usingUV/light spectroscopy. For example the collection container may includean optically clear section which is preferably incorporated into anoutside wall of the container, and a reflector section, which ispreferably on, or incorporated into, an inner wall of the container.“Optically clear” here means able to transmit light at the neededanalysis wavelength(s) through the optically clear section. Preferablythe optically clear section made of a material which is able to transmitUV light, such as polymethylmethacrylate, polystyrene, acrylic, quartz,etc. The wall thickness may need to be thin enough to allow theappropriate UV wavelength(s) to be transmitted through the opticallyclear section. For example, the thickness of the optically clear sectionmay be from around 0.5 mm to around 0.7 mm thick. Alternatively thethickness of the optically clear section may be from around 0.5 mm toaround 0.6 mm thick. Alternatively the thickness of the optically clearsection may be from around 0.6 mm to around 0.7 mm thick. Alternativelythe thickness of the optically clear section may be less than around 0.7mm thick.

A UV/light transmitter/receiver transmits UV or other wavelength lightin the appropriate wavelength through optically clear section, throughthe fluid in the collection container, to the reflector in thecollection container. The UV/light transmitter/receiver may beincorporated into, or connected to, the controller component of thechest drainage system. The light is reflected back to the UV/lightreceiver which then transmits the collected data to the controller forsignal analysis. More than one UV/light wavelength may be analyzedeither simultaneously or serially. Light outside of the UV range may beused in addition to light within the UV range. The volume of fluidphysically between the transmission and receiving of the light ispreferably maximized for a stronger signal reflecting the concentrationof one or more substances in the fluid. The transmitter/receiver may belocated in any area of the collection container. The receiver may be ina different location than the transmitter and the reflector may or maynot be necessary nor present. In embodiments where the fluid in thecollection container is frequently emptied, the UV/light absorptionmeasurements can be collected over time and increases and/or decreasesin the level of one or more substances in the drainage fluid can betracked over time, in essentially, or nearly, real time. This isparticularly important in identifying infection quickly. The UV/lightdetection may also be performed elsewhere in the chest drainage system,including in the drainage tubing, the chest tube, the valve device, aseparate sampling area etc.

Infection may be identified by analyzing the fluid for bacteria, redblood cells, and plasma and/or white blood cells using UV/lightspectroscopy. The presence of plasma/white blood cells and/or bacteriain fluid are both indicators of infection. The presence of red bloodcells may not be indicative of infection. Therefore it is desirable todistinguish between red blood cells and bacteria/plasma/white bloodcells in the drained fluid. Since the spectroscopic signature for redblood cells differs significantly from those of either bacteria orplasma/white blood cells, at a wavelength of about 414 nm, the signalfor red blood cells can be separated from those of bacteria and/orplasma/white blood cells, and an infection can be identified byanalyzing the absorption of light at this wavelength. Because thesignature for plasma and bacteria differ from each other at thewavelengths of 260 nm and 280 nm, these wavelengths can be used todistinguish between plasma and bacteria. However, it is likely that bothplasma and bacteria may be present during an infection.

Other wavelengths and other technologies may also be used to detectvarious substances in the drained fluid. UV/light absorption may also beused to detect turbidity. A dye or drug or reactive substance may alsobe introduced into the system, or be coated on the inside of the system,collection container, etc., to react with a substance in the drainedfluid to aid in analysis.

Example of Data Processing System

FIG. 15 is a block diagram of a data processing system, which may beused with any embodiment of the invention. For example, the system 1500may be used as part of the controller. Note that while FIG. 15illustrates various components of a computer system, it is not intendedto represent any particular architecture or manner of interconnectingthe components; as such details are not germane to the presentinvention. It will also be appreciated that network computers, handheldcomputers, mobile devices, tablets, cell phones and other dataprocessing systems which have fewer components or perhaps morecomponents may also be used with the present invention.

As shown in FIG. 15, the computer system 1500, which is a form of a dataprocessing system, includes a bus or interconnect 1502 which is coupledto one or more microprocessors 1503 and a ROM 1507, a volatile RAM 1505,and a non-volatile memory 1506. The microprocessor 1503 is coupled tocache memory 1504. The bus 1502 interconnects these various componentstogether and also interconnects these components 1503, 1507, 1505, and1506 to a display controller and display device 1508, as well as toinput/output (I/O) devices 1510, which may be mice, keyboards, modems,network interfaces, printers, and other devices which are well-known inthe art.

Typically, the input/output devices 1510 are coupled to the systemthrough input/output controllers 1509. The volatile RAM 1505 istypically implemented as dynamic RAM (DRAM) which requires powercontinuously in order to refresh or maintain the data in the memory. Thenon-volatile memory 1506 is typically a magnetic hard drive, a magneticoptical drive, an optical drive, or a DVD RAM or other type of memorysystem which maintains data even after power is removed from the system.Typically, the non-volatile memory will also be a random access memory,although this is not required.

While FIG. 15 shows that the non-volatile memory is a local devicecoupled directly to the rest of the components in the data processingsystem, the present invention may utilize a non-volatile memory which isremote from the system; such as, a network storage device which iscoupled to the data processing system through a network interface suchas a modem or Ethernet interface. The bus 1502 may include one or morebuses connected to each other through various bridges, controllers,and/or adapters, as is well-known in the art. In one embodiment, the I/Ocontroller 1509 includes a USB (Universal Serial Bus) adapter forcontrolling USB peripherals. Alternatively, I/O controller 1509 mayinclude IEEE-1394 adapter, also known as FireWire adapter, forcontrolling FireWire devices, SPI (serial peripheral interface), I2C(inter-integrated circuit) or UART (universal asynchronousreceiver/transmitter), or any other suitable technology.

Some portions of the preceding detailed descriptions have been presentedin terms of algorithms and symbolic representations of operations ondata bits within a computer memory. These algorithmic descriptions andrepresentations are the ways used by those skilled in the dataprocessing arts to most effectively convey the substance of their workto others skilled in the art. An algorithm is here, and generally,conceived to be a self-consistent sequence of operations leading to adesired result. The operations are those requiring physicalmanipulations of physical quantities.

It should be borne in mind, however, that all of these and similar termsare to be associated with the appropriate physical quantities and aremerely convenient labels applied to these quantities. Unlessspecifically stated otherwise as apparent from the above discussion, itis appreciated that throughout the description, discussions utilizingterms such as those set forth in the claims below, refer to the actionand processes of a computer system, or similar electronic computingdevice, that manipulates and transforms data represented as physical(electronic) quantities within the computer system's registers andmemories into other data similarly represented as physical quantitieswithin the computer system memories or registers or other suchinformation storage, transmission or display devices.

The techniques shown in the figures can be implemented using code anddata stored and executed on one or more electronic devices. Suchelectronic devices store and communicate (internally and/or with otherelectronic devices over a network) code and data using computer-readablemedia, such as non-transitory computer-readable storage media (e.g.,magnetic disks; optical disks; random access memory; read only memory;flash memory devices; phase-change memory) and transitorycomputer-readable transmission media (e.g., electrical, optical,acoustical or other form of propagated signals—such as carrier waves,infrared signals, digital signals).

The processes or methods depicted in the preceding figures may beperformed by processing logic that comprises hardware (e.g. circuitry,dedicated logic, etc.), firmware, software (e.g., embodied on anon-transitory computer readable medium), or a combination of both.Although the processes or methods are described above in terms of somesequential operations, it should be appreciated that some of theoperations described may be performed in a different order. Moreover,some operations may be performed in parallel rather than sequentially.

What is claimed is:
 1. A drainage assembly, including: a suction deviceconfigured to generate a negative pressure; a first lumen configured forinsertion into a patient body; a second lumen configured for insertioninto the patient body and fluidly coupled to the suction device; a valveassembly fluidly coupled to the first lumen and to the second lumen,wherein the valve assembly includes at least a first valve having aclosed configuration where the negative pressure generated by thesuction device is maintained within the second lumen, and the firstvalve further having an open configuration where the first valve isopened automatically based on a pressure differential across the firstvalve such that negative pressure draws air from an environment andthrough the first and second lumens; and a controller programmed toincrease the negative pressure to clear an obstruction within the secondlumen, wherein the controller is further programmed to decrease thenegative pressure within the second lumen after increasing the negativepressure.
 2. The assembly of claim 1 wherein the drainage assemblyincludes a chest tube.
 3. The assembly of claim 1 wherein the secondlumen is fluidly coupled to a drainage tube.
 4. The assembly of claim 1further including a drainage container in fluid communication with thesecond lumen.
 5. The assembly of claim 1 wherein the controller isprogrammed to increase the negative pressure upon detection of theobstruction.
 6. The assembly of claim 1 wherein the controller isprogrammed to continuously monitor the pressure.
 7. The assembly ofclaim 1 wherein the controller is programmed to intermittently actuatethe first valve into its open configuration.
 8. The assembly of claim 1wherein the controller is programmed to monitor the pressure in thevalve assembly.
 9. The assembly of claim 1 wherein the controller isprogrammed to monitor the pressure in proximity to the suction device.10. The assembly of claim 1 wherein the controller is programmed tomonitor the pressure in the second lumen.
 11. The assembly of claim 10wherein the controller is programmed to monitor the pressure inproximity to a chest of the patient body.
 12. The assembly of claim 1wherein the controller is programmed to monitor the pressure inproximity to a chest tube of the drainage assembly.
 13. A method fordraining a body lumen, including: applying a negative pressure to asecond lumen inserted into a patient body; drawing a fluid from thepatient body via the second lumen and through the second lumen in fluidcommunication with a first lumen; increasing the negative pressure toclear an obstruction from the second lumen; actuating a valve assemblyfluidly coupled to the first lumen and to the second lumen upon apressure differential forming across at least a first valve in the valveassembly such that the at least a first valve actuates automaticallyfrom a closed configuration, where the negative pressure is maintainedwithin the second lumen, and into an open configuration, where thenegative pressure draws air into the first lumen from an environment andthrough the second lumen; and decreasing the negative pressure withinthe second lumen after increasing the negative pressure.
 14. The methodof claim 13 wherein prior to actuating a valve assembly, furtherincluding monitoring via a pressure sensor for a decrease in thenegative pressure as indicative of an obstruction within the secondlumen.
 15. The method of claim 13 wherein actuating a valve assemblyincludes actuating via a controller in communication with the pressuresensor.
 16. The method of claim 13 further including introducing a chesttube into the patient body prior to applying a negative pressure. 17.The method of claim 13 further including draining the fluid into adrainage container in fluid communication with the second lumen.
 18. Themethod of claim 13 wherein prior to actuating a valve assembly furtherincludes monitoring via a pressure sensor for an indication of theobstruction within the second lumen.
 19. The method of claim 13 whereinprior to actuating a valve assembly further including monitoring for anincrease or decrease in pressure depending on a location of a pressuresensor.
 20. The method of claim 13 wherein monitoring via a pressuresensor includes continuously monitor the pressure.
 21. The method ofclaim 13 wherein actuating a valve assembly includes intermittentlyactuating the first valve into its open configuration.
 22. The method ofclaim 13 further including monitoring the pressure in the valveassembly.
 23. The method of claim 13 further including monitoring thepressure in proximity to the suction device.
 24. The method of claim 13further including monitoring the pressure in the second lumen.
 25. Themethod of claim 13 further including monitoring the pressure inproximity to a chest of the patient body.
 26. The method of claim 13further including monitoring the pressure in proximity to a chest tubeof the drainage assembly.